Recall Z-0224-2020 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Hycor Biomedical LLC
HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.
| Date | Jul 25, 2018 |
| Status | Open, Classified |
| Reason | Some of the Stop Solution bottles, a caustic solution, have been reported to leak. |
| Root cause | Employee error |
| Action | A Field Safety Notice dated 7/25/2018 was issued via email explaining there have been reports of leakage limited to the Stop Solution bottles, but there is no impact to patient results or performance of the kits. |
| Quantity | 185 individual bottles (170 US and 15 OUS) and 1,298/1-bottle kits (OUS) |
| Distribution | Stop Solution bottles were distributed to AL, CA, FL, IL, KS, LA, MS, NJ, NY, SC, TX, WA, and to the U.S. Virgin Islands. Foreign distribution of the bottles was made to Germany. There was no government/military distribution. Assay kits containing the Stop Solution bottles were distributed to F |
| FDA record | Open on fda.gov |